Systems, methods and apparatus for respiratory support of a patient

ABSTRACT

Spontaneous respiration is detected by sensors. An additional amount of oxygen is administered to the lungs via a jet gas current at the end of an inhalation procedure. Breathing volume, absorption of oxygen during inhalation, and clearance of carbon dioxide during exhalation are improved. If required, the exhalation procedure of the patient can be arrested or slowed by a countercurrent to avoid a collapse of the respiration paths. An apparatus including an oxygen pump can be connected to an oxygen source and includes a tracheal prosthesis that can be connected via a catheter. The respiration detections sensors are connected to a control unit for activating the oxygen pump. The tracheal prosthesis includes a tubular support body with a connection for the catheter, and the sensors are associated with the support body. The tracheal prosthesis and jet catheter are dimensioned so the patient can freely breathe and speak without restriction.

PRIORITY CLAIM

This patent application claims priority to U.S. Ser. No. 60/718,318,“Systems, Methods and Apparatus for Respiratory Support for a Patient”,filed Sep. 20, 2005, which is incorporated herein by reference in itsentirety.

FIELD OF INVENTION

The present invention relates generally to respiratory systems and moreparticularly to specialized systems, methods, and devices for enhancedventilation of a patient.

BACKGROUND OF THE INVENTION

In order for the body to take in oxygen and give off carbon dioxide, twocomponents of the respiratory bronchial system must function—the lungsas a gas-exchanging organ and the respiratory pump as a ventilationorgan that transports air into the lungs and back out again. Thebreathing center in the brain, central and peripheral nerves, theosseous thorax and the breathing musculature as well as free, stablerespiratory paths are necessary for a correct functioning of therespiratory pump.

In certain diseases there is a constant overload on or exhaustion of therespiratory pump. A typical syndrome is pulmonary emphysema withflat-standing diaphragms. Flat-standing diaphragms do not have theability to contract. In the case of pulmonary emphysema, respiratorypaths are usually extremely slack and tend to collapse. As a consequenceof the flattened, over-extended diaphragms, the patient cannot inhaledeeply enough. In addition, the patient cannot exhale sufficiently dueto collapsing respiratory paths. This results in an insufficientrespiration with an undersupply of oxygen and a rise of carbon dioxidein the blood, i.e. a ventilatory insufficiency.

The treatment for inhalation difficulty often involves a breathingdevice. A home ventilator is an artificial respirator for supporting orcompletely relieving the respiratory pump. Artificial respiration can beapplied non-invasively via a nose or mouth mask that the patient can puton and take off as needed. However, the nose or mouth mask prevents thepatient from breathing and speaking freely, and is very invasive.

Another treatment option is invasive ventilation. Invasive ventilationis usually applied via a cuffed endotracheal tube that is passed throughthe mouth and the larynx and into the windpipe, or is applied via atracheostomy. The tracheostomy involves an opening placed in the tracheaby an operation. A catheter about the diameter of a finger with ablocking balloon or cuff is inserted via the opening into the tracheaand connected to a ventilator that applies cyclic positive pressure.This procedure makes sufficiently deep respiration possible, butprevents the patient from speaking.

In addition to home ventilation with a mask and invasive ventilation,there is also transtracheal administration of oxygen via thinnercatheters. U.S. Pat. Nos. 5,181,509 or 5,279,288 disclose correspondingembodiments. In this manner, a highly dosed administration of oxygen isadministered to the patient in a continuous stream with a permanentlyadjusted frequency. The flow rate of oxygen is regulated manually by aregulator. However, simulation of the natural breathing process of apatient is not achieved because the depth of breathing is not enhanced.Some common problems associated with these transtracheal catheters areirritations and traumas of the sensitive inner skin of the windpipe(tracheal mucosa). It is a common observation that the tip of the smallcatheter strikes against the inner wall of trachea as a consequence ofthe respiratory movement. In addition to this mechanical trauma, thesurrounding tissue is dried out by the high flow oxygen stream.

Furthermore, so-called “Montgomery T-tubes” can be inserted into thetrachea and a patient can obtain oxygen via a shank of the T-pieceexternal to the patient. In needed, the patient can draw off secretionsusing a suction catheter and a vacuum pump. The patient can breathefreely and speak when the front shank is closed; however, normalartificial positive pressure ventilation is not possible via theMontgomery T-tube since the introduced air escapes upward into the oralcavity or the pharyngeal area. An additional limitation of theabove-referenced therapies is the impaired mobility of the patientbecause of inadequate ventilation or because of the bulk of theapparatuses.

Jet ventilators are state of the art, but these devices are notsynchronized with a patient's breathing. On the other hand, invasiveventilators with cuffed tubes are synchronized because there is a directfeedback of the pressure inside the inflated lung to the sensors insidethe respirator. However, there are no respiratory systems that usefeedback from sensors in the body to properly synchronize and controlthe ventilator.

Whether the breathing disorder is COPD/emphysema, fibrosis, sleep apnea,or otherwise, difficult breathing is a serious, often life-threateningproblem. Therefore, there is an existing need for a respiratory systemthat provides a more efficient method for supporting the respiration ofa patient that can be used to treat many disorders, are minimallyinvasive, mobile and taken along by the patient, and/or reliable in use.Moreover, there is a need for respiratory support systems that simulatethe patient's spontaneous respiration without adversely affecting thepatient's ability to speak. Additionally, there is a need for arespiratory support system capable of using pressure or flow signalsfrom inside the body to properly synchronize and control a ventilator.

SUMMARY OF EXEMPLARY EMBODIMENTS

The invention includes systems, methods, and apparatuses that improvethe quality of life for patients that require respiratory support. Theserespiratory systems, methods, and apparatuses can provide a moreefficient way of supporting the respiration of a patient by providingadditional oxygen when needed in accordance with the principles of theinvention.

In one embodiment, a tracheal prosthesis and a catheter in accordancewith the principles of the invention can provide for respiratory supportthat can be synchronized with the spontaneous respiration of the patientand still allow the patient to speak.

Additional features, advantages, and embodiments of the invention may beset forth or apparent from consideration of the following detaileddescription, drawings, and claims. Moreover, it is to be understood thatboth the foregoing summary of the invention and the following detaileddescription are exemplary and intended to provide further explanationwithout limiting the scope of the invention as claimed.

BRIEF DESCRIPTION OF THE FIGURES

The accompanying drawings, which are included to provide a furtherunderstanding of the invention, are incorporated in and constitute apart of this specification, illustrate preferred embodiments of theinvention and together with the detailed description serve to explainthe principles of the invention.

In the drawings:

FIG. 1 shows the upper body of a patient carrying an embodiment of asystem for respiration support in accordance with the principles of theinvention.

FIG. 2 shows a diagram with a view of the respiration flow of anemphysema patient without respiration support and with respirationsupport in accordance with the principles of the invention.

FIG. 3 shows a technically simplified view of an embodiment of atracheal prosthesis in accordance with the principles of the invention.

FIG. 4 shows another embodiment of a tracheal prosthesis in accordancewith the principles of the invention.

FIG. 5 shows a schematic of an embodiment of an oxygen-bearing gas tankand pump showing the conduction of air and a control unit in accordancewith the principles of the invention.

FIG. 6 shows an embodiment of the end section of a catheter inaccordance with the principles of the invention.

FIG. 7 shows the catheter according to FIG. 6 inserted in a support bodyin accordance with the principles of the invention.

FIGS. 8A and 8B show graphs of breathing data generated from a benchmodel test in accordance with the principles of the invention.

FIG. 9 shows an embodiment of a catheter and sensors in accordance withthe invention.

FIG. 10 shows a schematic of an embodiment of a circuit in accordancewith the invention.

FIG. 11 shows another embodiment of a catheter and sensors in accordancewith the invention.

FIG. 12 shows a schematic of another circuit in accordance with theinvention.

FIG. 13 shows a system in accordance with an embodiment of the inventionwhere the pump and control unit are integrated with the oxygen tank.

FIG. 14 shows an embodiment of a distal end of a catheter in accordancewith the invention.

FIG. 15 shows another embodiment of a distal end of a catheter inaccordance with the invention.

FIGS. 16 A-16E shows embodiments of a catheter in accordance with theinvention.

FIG. 17 shows an embodiment of a dual lumen catheter in accordance withthe invention.

FIG. 18 shows an embodiment of the flow through the catheter of FIG. 17during inspiration in accordance with the principles of the invention.

FIG. 19 shows an embodiment of the flow through the catheter of FIG. 17during expiration in accordance with the principles of the invention.

FIG. 20 shows an embodiment of a dual lumen catheter having a glidingwall in accordance with the invention.

FIG. 21 shows the catheter of FIG. 20 with the gliding wall in adifferent position.

FIG. 22 shows an expanded view of an air outlet of the catheter in FIG.20.

FIG. 23 shows an expanded view of an air outlet of the catheter in FIG.21.

FIG. 24 is a flow diagram illustrating the operation of an embodiment ofthe invention.

FIG. 25 is a diagram of the overall system.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

The present invention, in a preferred embodiment, provides systems,methods, and apparatus for supporting the respiration of a patient. Thiscan be accomplished by providing controlled synchronized ventilationwith a directed flow of an oxygen-bearing gas. The oxygen-bearing gasmay be substantially pure oxygen, mixtures of oxygen and nitrogen,mixtures of oxygen and inert gases, ambient air, or various combinationsthereof. In addition, the oxygen-bearing gas may include fragrances,aerosolized drugs, humidification or heating. The oxygen-bearing gas canbe provided as needed upon inhalation and/or expiration, preferably,based upon sensing of the patient's spontaneous breathing.

By providing a jet boost of an oxygen-bearing gas upon inspiration, asneeded, the patient can inhale more oxygen. Preferably, the additionaloxygen is administered at the end of inhalation, in particular, afterthe peak of inspiratory flow is detected. The administration ofadditional oxygen can improve the depth of ventilation duringinhalation. However, the additional oxygen may be administered at anypoint during inhalation. Additionally, a countercurrent or counter pulseduring expiration can be delivered, which creates a back-pressure in theairways similar to the pursed lips breathing strategy applied byphysiotherapists in order to avoid a collapse of the respiration paths.By providing an oxygen-bearing gas upon expiration through counterpulses (e.g. bursts or pulses of oxygen-bearing gas directed against thedirection of the flow during expiration), a dynamic collapse of theairways can be minimized or prevented, over inflation of the lung can beminimized, and clearance of carbon dioxide from the lungs can beimproved. Therefore, in accordance with the principles of the invention,whether used for inhalation and/or exhalation, breathing requires lessenergy and the patient's pain, dyspnea and exhaustion are relieved.Moreover, the systems and methods of the invention can be used fortreatment of many breathing disorders, including, but not limited to,COPD, emphysema, fibrosis, and sleep apnea.

Referring to FIG. 1, in accordance with one embodiment of the invention,patient P designates a patient suffering from a breathing disorder, forexample, pulmonary emphysema, with overloading and exhaustion of therespiratory muscles. As a consequence, the patient cannot inhale enoughoxygen because the lungs are compromised. In addition, the patientcannot exhale enough carbon dioxide because the patient has slack andcollapsing respiratory paths. The system of FIG. 1 generally includesthe ability to detect the patient's spontaneous respiration and theability to provide oxygen to the lungs of the patient during spontaneousinspiration and/or exhalation.

As shown, the respiration support of patient P in accordance with theprinciples of the invention can be implemented in a system, method, orapparatus that may be compact and/or portable. Other systems arecontemplated including, for example, providing for use with a ventilatoror oxygen source as shown in FIG. 13. The overall system of theinvention is described in FIG. 25, indicating the gas source O2, thepump apparatus 1 and control system 12, the catheter 5 and internalsensors 8, 9 and the patient P. The gas source O2, pump apparatus 1 andcontrol system 12 can be separate or integrated components of thesystem. The control unit 12 may be connected I to internal sensors 8, 9and/or external sensors 13, 14.

In accordance with the embodiment of FIG. 1, in general, patient P'sspontaneous breathing can be detected by way of sensors. A catheter 5can be used to introduce oxygen into the lungs as needed. The sensorsand catheter can be associated with the patient in a variety of ways. Asillustrated in FIG. 1, a catheter 5 is introduced in the trachea. Also,a catheter 5 could be introduced at other points into a patient P,including, for example, through the mouth or nose of the patient P, oraccessed into the trachea by an artificially created entry pointsomewhere on the body and tunneled internally to and into the trachea.The catheter 5 can be secured in the trachea in a variety of ways. Inone embodiment, the catheter 5 can be associated with a trachealprosthesis as discussed later or using a positioning catheter as alsodiscussed later with reference to FIGS. 3 and 4, for example.

The system of FIG. 1 generally includes an oxygen-bearing gas source(not shown), gas pump 1, mobile respiratory device 4, a set of exteriorsensors 13, 14, and a set of interior sensors (not shown) disposedinside the trachea of the patient P. The oxygen-bearing gas pump 1 canbe connected to a gas source (see FIG. 5) and catheter 5 to introduce anoxygen-bearing gas into the patient's lungs by way of the trachea, asshown, although other entry points can be used in accordance with theprinciples of the invention as discussed above. According to FIG. 1, theoxygen-bearing gas pump 1 is shown as a component of a compact, easilyportable respiration device 4. The device 4 could alternatively behoused in a component with a gas tank or oxygen-bearing gas source asillustrated in FIG. 13. With the sensors in accordance with theprinciples of the invention, the spontaneous respiration of the patientcan be detected. Typically, the information from the sensors iscommunicated to the gas pump 1. However, the information from thesensors may also be communicated to a cellular telephone or otherwireless systems that can communicate information to a healthcareprovider/hospital, etc., for 24-hour monitoring and response from thehealthcare provider/hospital, etc. The patient then can receive apressure boost of oxygen-bearing gas as needed in accordance with theprinciples of the invention. FIG. 2 illustrates both spontaneousrespiration of the patient P without the invention (right) andrespiration supported in accordance with the principles of the invention(left). The x-axis in this diagram represents time and the y-axisrepresents the amount of flow (change in volume over time) ofoxygen-bearing gas, which can be liters per second or any otherappropriate measurements. The spontaneous respiration process withinspiratory flow and expiratory flow without respiratory support forpatient P is shown in the left half of FIG. 2. The curve for inhalationis designated by E1 and the curve for exhalation by A1. As illustratedby curve E1, during inhalation the tidal volume inhaled is reduced fromthat of a normal patient. For example, a patient with emphysema withflattened diaphragms or a patient with stiff lungs suffering fromfibrosis cannot breathe in enough air (oxygen) in one breath. Bothpatients typically experience shallow breathing. Therefore, the patientrequires more breathing cycles to get the requisite amount of oxygen andclear carbon dioxide. During exhalation, as illustrated by curve A1, theexpiratory flow of the emphysema patient is reduced because therespiratory paths can be slack and tend to collapse before an adequateamount of carbon dioxide is expelled from the lungs.

The sensors allow the patient P's breathing to be monitored continuouslyso that a jet flow of oxygen-bearing gas can be supplied in accordancewith the principles of the invention, that is, when a deeper breath isneeded. In particular, at the end of an inhalation process of the lungs,an additional volume (oxygen) can be administered to patient P, asdiscussed in more detail below. This respiratory flow is illustrated inthe right half of FIG. 2. As illustrated, an additional amount ofoxygen-bearing gas provided to patient P increases the respiratoryvolume during inhalation according to curve E2 by the volume differenceshown darkened in the upper curve and designated by E3. The additionalamount of oxygen-bearing gas can have an extra space tidal volumebetween 25 ml and 150 ml.

In addition, the exhalation process of the patient can be braked orslowed by a countercurrent. As a consequence thereof, the respiratoryflow shifts during exhalation along the curve designated by A2. Thispurposeful resistance acting opposite to the exhalation prevents acollapsing of the respiratory paths during exhalation. In this manner,the exhalation volume can be increased by the volume also shown darkenedand designated by A3. The amount of carbon dioxide that is exhaled canbe increased by a statistically significant amount. The amount of carbondioxide that is exhaled can be increased by at least 5%. Preferably, theamount of carbon dioxide exhaled is increased from 5% to 30%. Morepreferably, the amount of carbon dioxide exhaled is increased about 20%to 30%.

As a consequence, the invention may avoid insufficient respiration froman undersupply of oxygen and an increase of carbon dioxide in the blood.The patient P may be significantly less stressed and more mobile, andmay perceive less or no shortage of air.

The sensors for detecting and monitoring respiration will now bediscussed in more detail. To detect spontaneous respiration of thepatient P, sensors can be associated with an end of the catheter that isdisposed in the trachea of the patient P. In one embodiment, theinvention can include connecting the catheter to a tracheal prosthesis(e.g. FIGS. 3, 4, and 7) or can include a catheter-positioning device(e.g. FIGS. 14, 15, and 16A-16E) to more reliably and accurately directthe oxygen flow into the patient's airways and away from a trachealwall. Preferably, in accordance with the principles of the invention,oxygen is introduced into the patient P in such a manner that thepatient P can freely breathe and speak without restriction.

In one embodiment, as shown in FIGS. 3 and 4, the sensors can bedisposed on a tracheal prosthesis 2, 3. Each tracheal prosthesis 2, 3 isshown having a tubular support body 6 with a connection 7 for a catheter5. As shown, two sensors 8, 9 detect spontaneous respiration of thepatient P, and can be associated with a support body 6. The sensors 8, 9can be thermistors, that is, temperature dependent resistors. Thesensors 8, 9 can detect tracheal flow of the patient because inspiredair and expired air have different temperatures. The thermistors 8, 9can be connected together in a bridge circuit in the apparatus tocompensate for changes in ambient air temperature. Other types ofsensors can be used in accordance with the principles of the inventionincluding, for example, a pressure sensor as discussed later. Bothsensors 8, 9 can be located on an inner wall 10 of the support body 6(FIG. 3), or one sensor 8 can be fixed on the inner wall 10 of thesupport body 6 and the other sensor 9 can be located on an outer wall 11of the support body 6 (FIG. 4). The sensors 8, 9 communicate with acontrol unit 12 for activating an oxygen jet pump 1. The sensors 8, 9can be connected by wires or by wireless communication. The control unit12 can be any type of microprocessor that is capable of processing thecollected data in accordance with the invention. The control unit 12 isschematically shown in FIG. 5 with its inputs (I) and outputs (O). Theinputs (I) represent information coming from the sensors. The outputs(O) represent information that is used to control the pump 1.

In the tracheal prosthesis 2 according to FIG. 3, the jet catheter 5 canbe inserted via connection 7 into the support body 6. An end 15 of jetcatheter 5, located in support body 6, is preferably guided or deflectedapproximately parallel to its longitudinal axis L. The data lines fromsensors 8, 9 to the control unit 12 run inside the catheter 5. Theinvention is not limited to data lines; transmission from sensors can beany type of transmission, including wireless. On the discharge side, theend 15 of the jet catheter 5 is preferably designed as a jet nozzle 25.The jet nozzle 25 increases the speed of an oxygen current beingdischarged from the catheter 5, and the current is conducted in thedirection of the bronchial tract. The diameter of the support body 6 isdimensioned with a sufficiently free lumen in such a manner that thepatient P can freely breathe and speak even with the integrated catheter5.

In another embodiment, a separate coupling 18 is provided on theconnection 7 in the tracheal prosthesis 3 according to FIG. 4. Thecatheter 5 can be connected to the tracheal prosthesis 3 with theseparate coupling 18. In this instance, a fixed longitudinal section 19aligned parallel to the longitudinal axis L can serve as the catheterend in the support body 6, and the oxygen current is conducted via a jetnozzle 26 in the direction of the bronchial tract.

The tracheal prosthesis, when used, can comprise various configurations,shapes and dimensions. For example, the tube could be T-shaped orL-shaped or otherwise. The size, shape, and/or cross-section can vary,for example, to accommodate removal or to direct the catheter. Thetracheal prosthesis could be a portion of a tube having, for example, asemi circular cross-section. Furthermore, expandable and self-expandableprongs or petals can be used at the tracheal opening to secure theprosthesis in place. In one embodiment, the prosthesis can include atubular member with a tracheal side opening including prongs or petalssurrounding, in whole or in part, the access hole. The prongs or petalsmay function like a rivet in the neck opening. The tracheal prosthesiscan also be coated to avoid mucus retention, prevent the formation ofgranulation tissue, or can act as a drug-releasing device. The trachealprosthesis may also include other coatings, such as lubricious coatingsand hydrogel anesthetics. Thus, the tracheal prosthesis can serve as aguide for the catheter, to hold sensing devices, serve as a drugdelivery device, and/or to minimize mucus plugs that can form on thecatheter tip.

In addition to internal sensors, external sensors can be provided. FIG.1 also shows respiration sensors 13, 14, preferably, impedanceelectrodes or respibands. Signals from the sensors 13, 14 are also fordetecting the spontaneous respiratory efforts of the patient P. An exactimage of the respiration process of patient P can be obtained byprocessing the measured values received via sensors 8, 9 and 13, 14. Inaddition, the safety against false measurements or the failure of one ofsensors 8, 9 and/or 13, 14 can be increased due to redundancy. Althoughthe sensors are shown in certain locations on the patient P, otherlocations that would allow the sensor to sense the patient'srespiration, directly or indirectly, can be used. For example, sensorscan be provided on the catheter as discussed later. Alternatively, apill-type sensor or nano device can be used and/or implanted tocommunicate by, for example, wireless transmission to communicate withthe control unit to operate the oxygen flow through the catheter inaccordance with the principles of the invention.

One embodiment where sensors are provided on the catheter is shown inFIG. 6. FIG. 6 shows a catheter 28 with a long, flexible tube 29 and anend 31 on the discharge side bent in a curvature 30. The catheter 28 canbe preformed to provide a desired curvature 30. With the appropriatecurvature 30, the catheter 28 can be entered into the trachea with orwithout use of a prosthesis. In this embodiment, two sensors 32, 33 fordetecting the spontaneous respiration of the patient P can be fastenedon the end of the catheter 28. The sensors 32, 33 are preferablythermistors, but as in all embodiments herein, could be other types ofsensors. Furthermore, in other embodiments of the invention, additionalsensors may be used. In still other embodiments of the invention, fewersensors may be used. Data lines are not shown in the drawing for thesake of simplicity and could include any form of data transmission. In ahard-wired embodiment, data lines can run through the catheter 28. Acatheter flange 34 designates a stop for use with a support body 36, asshown in FIG. 7. It can also be seen that an end 31 of the catheter 28is provided with a jet nozzle 35. The cross-section of gas flow isreduced relative to the cross-section of the catheter 28 in the jetnozzle 35 so that the discharge rate of the supplied oxygen isincreased.

The catheter 28 can be introduced into the support body 36, as shown inFIG. 7. The support body 36 is located in the trachea of the patient P.A connection to the outside is established via a connection 37. In thebody, the tip or jet nozzle end 35 of the catheter 28 can be disposed inthe trachea. Preferably, the tip of the catheter 28 does not touch thetracheal wall. The support body 36 can be a traditional MontgomeryT-stent.

FIGS. 8A and 8B show measurements in a lung model emulating respiratorydiseases. FIGS. 8A and 8B graphically illustrate an increased tidalvolume with the invention. FIG. 8A shows a bar graph of the volume (ml)of breath comparing a pathologically low breath of a patient withemphysema at about 90 ml; the volume with jet oxygen in accordance withthe principles of the invention upon inhalation at about 260 ml; and thevolume with the jet oxygen in accordance with the principles of theinvention upon inhalation and with the flow brake (oxygen jet) uponexhalation at about 300 ml. FIG. 8B shows a graph of the flow of breath(liters per second) over time for a breath of an emphysema patient; theflow with jet oxygen in accordance with the principles of the inventionupon inhalation; and the flow with jet oxygen in accordance with theprinciples of the invention upon inhalation and with the flow brake(oxygen jet) upon exhalation.

In another embodiment shown in FIGS. 9 and 10, thermistors 81 and 82 canbe provided on a catheter tip inside the trachea. The thermistor 81 ismore exposed to the gas stream than thermistor 82, which is protectedagainst fast temperature changes because it is inside the catheter wall(or under a protection film). Alternatively, multiple thermistors withdifferent response times could be used. Over a longer period (e.g. 10seconds), both mean temperatures will be the same (equilibrium) and thebridge (FIG. 10) will be readjusted. This compensates for changes inambient temperature, fever, etc. Rapid changes based upon breathing incolder air and breathing out warmer air is detected by the thermistor81. The output signal is sent through a differentiator. The peaks of thethermistor signal match the highest flow rates. The minimum in thedifferentiated signal matches the peak of the inspiratory flow and thepeak of the expiratory flow. Undifferentiated and differentiated signalsare fed into the microprocessor. One way to determine peak inspiratoryflow (trigger for beginning introduction of oxygen) would be to look forminimum in absolute temperature (cold air comes in) and zero change oftemperature (differentiated signal is zero). The advantage of using theabove multiple thermistor approach is that the difference between thesignals from the two thermistors cancels out flow artifacts found in themeasured respiratory flow pattern, such as would be caused by vibrationor other anticipated events, and to compensate for drift in thethermistor signal such as would be caused by changing external orinternal temperature or humidity conditions.

In another embodiment, as shown in FIGS. 11 and 12, FIG. 11 shows apressure transducer that is a modified silicone wire strain gaugeelement 90. Instead of a typical silicone membrane, the wall of thecatheter is used. If the wall of the catheter deforms under the pressureswings inside the trachea (breathing effort), then an electrical signalfrom the bridge amplifier is fed into a microprocessor. This embodimentcan be used alternatively to the thermistors, as a redundant signal oras a back-up signal. Other sensors could be semiconductor flow sensorsor pressure sensors. FIG. 12 shows a circuit diagram of a bridgeamplifier.

Other sensors can be used in accordance with the invention. For example,sensors and/or secondary control sensors could be: respibands (chestwall strain gages), respitrace signals (conductance plethysmographs),pressure sensors inside or outside the body, transthoracic electricalimpedance measuring devices, flow sensors at the mouth or nose(pneumotachographs), and/or capnometers (carbon-dioxide sensors).Moreover, the sensors in accordance with the invention can communicatedata or information to the control unit by any devices, mechanisms, ormethods. For example, communication can occur by way of wire, wireless,or remote transmission. The advantage of using non-thermistor sensors isthat the thermistor approach may have the disadvantage of the thermistorhead collecting airway mucus, which could be corrected for in a varietyof ways such as with cleaning. However, other non-thermistor sensors maybe less susceptible to annoyances like mucus collection. Further, withthermistor sensors, inevitable changes in ambient temperature, whilecompensatable in the thermistor signal processing algorithms, arepotentially problematic to system reliability. Therefore, the othertypes of sensors stated above may be advantageous over thermistorsensors, or in addition to the thermistor sensors.

In addition to measuring the respiration pattern, it is often desirableto measure airway pressure for safety reasons, for which thermistorsensors may not be the best approach. Therefore, some of the sensorsmentioned above can also be used as a safety control device. Forexample, pressure sensors can be used to sense the inspiration of thepatient (like the thermistors), but they can also be used to sense ahigh pressure in the trachea and shut off the jet machine in order toprevent baro-trauma (damage from high pressure).

An oxygen-bearing gas is provided on demand by the gas pump 1. The gaspump 1 is schematically shown in FIG. 5. The gas pump 1 can be a pistonpump with a double-acting piston 20 arranged in a cylinder 27. Thepiston pump of the present embodiment comprises four valves V1 to V4.Other piston pumps (not shown) may have greater than or fewer than fourvalves. The supply of oxygen emanates from an external oxygen reservoirvia a connection 21. The switching states of valves V1 to V4 and thesupply lines and removal lines are designated by letters a to g. Othertypes of pumps can be used in accordance with the principles of theinvention.

The gas pump 1 functions in the apparatus during the support ofrespiration as follows. When valve V1 is open from c to a (b to cclosed) and valve V2 is open from b to e (e to d closed), piston 20moves to the left in the plane of the figure and the oxygen flows viaoutlet 22 and jet catheter 5 to the patient P. An additional amount ofoxygen E3 is administered during the inhalation process of the patientP.

When valve V1 is open from b to c (c to a closed) and valve V2 is openfrom e to d (b to e closed), piston 20 moves to the right in the planeof the figure and the flow of oxygen takes place in the direction ofvalve V3. Valve V3 is connected to the ambient air via an outlet 23. Inthe instance in which valve V3 is open from d to g, the oxygen flows offwithout expiration brake. That means that the exhalation process is notbraked by a countercurrent.

If valve V3 is closed from d to g and open from d to f, the oxygen flowsvia access path 24 in the direction of the outlet 22 and the catheter 5in order to be administered to the patient P during the exhalationprocess and in order to break the respiratory flow. The countercurrentprevents a collapsing of the respiratory paths and keeps them open,making a deeper exhalation possible.

Furthermore, valve V4 is located in access path 24 of the apparatus, viawhich the flow through (f to a) can be variably adjusted. Thisadvantageously can be a proportional valve with pulse-width modulation.

As discussed above, the catheter preferably includes a jet nozzle. Anytype of jet nozzle can be used to achieve the necessary jet flow. Thejet flow speed in accordance with the invention can be significantlyhigher than 100 m/s. By comparison, the speed through a conventionalventilator tube or mask is significantly lower than 100 m/s. When thejet flow rate is high enough, there is enough speed so that directedflow is accomplished and no sealing tube cuff would be necessary. Undernormal ventilation, the volumetric inspiratory flow rate is in the rangeof about 500 m³ to 1000 cm³ in 2 seconds. A peak inspiratory flowmaximum can be 1000 cm³/second. In the case of normal invasiveventilation, the flow of 1000 cm³/s (peak) goes through a tube ofapproximately 8 mm diameter. The speed of this gas stream, determined bydividing the volumetric inspiratory flow rate by the area of the tube,is 1000 cm³/(0.4)² cm²*Pi=2000 cm/s=20 m/s. During jet ventilation,approximately half of this flow goes through a jet cannula of 1.5 mmdiameter. As the flow profile is rectangular, the peak flow rate is 500cm³/s. Therefore, the speed of the jet gas stream is 500 cm³/(0.075)²cm²*Pi=28313 cm/s=283 m/s. In accordance with a preferred embodiment ofthe invention, 100 ml (cm³) are pressed through a catheter of approx 1.5mm diameter in half a second. Preferably, the peak flow for thisembodiment is 100 cm³ in 0.25 seconds=400 cm³/s. The speed of this gasstream is 400 cm³/(0.075)² cm²*Pi=22650 cm/s=226 m/s. In other preferredembodiments, the speed of the gas stream is from approximately 100 m/sto approximately 300 m/s. Preferably, the speed of the gas stream isfrom approximately 200 m/s to approximately 300 m/s. Preferably, thespeed of the gas stream is from approximately 250 m/s to approximately300 m/s.

When the tip of the catheter touches the wall of the trachea, there is apotential risk of tissue damage. The catheter tip or the high flow gasstream can harm the mucosa. To efficiently and effectively direct theair inside the body, the catheter can be configured to provide adirected flow of oxygen. In particular, the catheter is preferablyconfigured so that the exit of air from the catheter output end canexpel and direct air down the center of the trachea to avoid directingthe jet flow of oxygen against the tracheal wall. Also, the cathetertips are preferably configured to minimize venturi and the mucusformation proximal to the venturi on the outer wall of the catheter. Ashielding Montgomery T-tube as described above can be used to overcomethat problem. In FIGS. 14 and 15, the catheters are configured such thatthe catheter tip or jet nozzle avoids contact with the wall of theairway, the tip is substantially centered in the trachea. This can beaccomplished by configuring the catheter so that the catheter willcontact the tracheal wall at several locations to distribute the localpressure, and the tip where the jet flow of oxygen exits the catheter issubstantially centered in the trachea. Accordingly, the use of atracheal prosthesis is not necessary. One way to avoid the contactbetween the tip Get nozzle) and the airway wall is to bend the catheterlike a zigzag in two planes as illustrated in FIG. 14. Anotherembodiment is a corkscrew as illustrated in FIG. 15.

FIGS. 16A-16E show alternate embodiments for centering the catheterwhere balloons (FIGS. 16A and 16B) or clips (FIGS. 16C-16E) can be usedto center the catheter tip. FIG. 16A shows a balloon for centering thecatheter tip where the balloon has a roughly circular cross sectionthrough line J-J. Openings in the balloon may be located in thelongitudinal direction of the catheter. FIG. 16B shows a balloon forcentering the catheter tip where the balloon can have multipleextensions. The extensions may appear as cone-shaped projections incross section K-K along the longitudinal direction of the catheter. FIG.16C shows clips extending radially out from the catheter. The clips inthis embodiment are relatively flat and extend outward in opposingpairs. FIG. 16D shows another embodiment of clips with extensions on theend of the clips. The clips and extensions may extend at multiple anglesrelative to the catheter for centering the catheter tip within thetrachea. FIG. 16E shows another embodiment of clips having shapedprotrusions at various locations along the length of the catheter. Theprotrusions may have flat tops with rounded edges and undercuts.Preferably, the clips of the various embodiments are made of a resilientmaterial.

Referring now to FIGS. 17-23, a dual lumen catheter will be described.The invention can also include the ability to better distribute thedirected flow (FIGS. 17-19) and/or change the direction of the flow(FIGS. 20-23). FIGS. 17-19 show a dual lumen catheter 172. The cathetertip, shown generally at 170, is disposed in a trachea 174. The catheter172 has two lumens, formed by inner cannula 176 and outer cannula 178.Inner cannula 176 directs flow to a catheter nozzle 180, as discussedabove. As shown in FIG. 18, upon inspiration, inspired flow is enhancedby air entrainment from the jet flow through the inner cannula plus bythe additional jet flow itself 176. Upon expiration (FIG. 19), exhaledflow is enhanced by turbulence from counter flow through ports 182 bymeans of propping the respiratory paths open. The ports 182 need not beof any particular shape and may be, for example, circular, hexagonal,oval, or slits. Although not shown, turbulent flow could also beprovided through inner cannula 176 during exhalation to enhance exhaledflow depending upon the desired effect.

Referring to FIGS. 20-23, another embodiment of a catheter is shown. Acatheter 200 is shown with a distal tip 202 in a trachea 204. Thecatheter tip 202 includes a cannula configuration with an inner lumen206, an outer lumen 208 concentric to the inner lumen, and a glidingsheath 210. In this embodiment, the gliding sheath 210 moves relative tothe cannula to allow ports 210 to change the direction of oxygen flow asillustrated in FIG. 20 verses FIG. 21, and in close-up in FIG. 22 versesFIG. 23. As shown in FIG. 22, upon expiration, the flow brakingturbulence caused by movement of the gliding sheath 210 may create aresistance such as in pursed-lip breathing, which can prop therespiratory paths open to enhance the amount of exhaled volume. Or, asshown in FIG. 23, the addition of venturi flow towards the mouth causedby movement of the gliding sheath 210 can entrain exhaled flow toenhance the overall exhaled volume. Although the gliding sheath 210 isshown to move, more or other parts can be made to move to accomplish thedirected flow of this embodiment. For example, flow braking turbulenceor venturi flow toward the mouth may be produced by the use of shutters,louvers, or slats.

Regardless, the flow can be directed towards the mouth or back into thelungs as desired. The flow brake for the expiratory flow of the patientcan be adjusted from disturbance (pursed lips effect) or to augmentation(venturi principle). The whole catheter preferably does not have morethan 4 mm outer diameter, but can be very versatile. This embodiment,like the other embodiments of the invention, can also be used to applyvibratory flow to the respiratory paths to improve mucus clearance.

The system in accordance with the principles of the invention can beimplantable. In one embodiment, the system including the jet catheterand system sensors can be implanted inside the body. Although it ispossible to implant the pump, it is contemplated that tubing attached tothe pump can be connected to a connector exposed from the body. The pumptubing can be attached to the connector in a conventional manner so thatthe oxygen-bearing gas flows through the implanted jet catheters intothe patient in accordance with the principles of the invention. Thesystem can be tailored to the needs of the patient. The jet pressure andtiming and duration of the pulses can be monitored and controlled andadjusted as necessary based on the patient's respiratory condition andgeneral status. As shown in FIG. 1, the catheter can extend along theoutside of the body. Alternatively, the catheter could be implantedinside the patient's body. For example, the catheter could have oneexposed end for connection with the pump and some or all of theremainder of the catheter could be implanted inside the patient and/orunder the skin of the patient. The output end of the catheter could, forexample, be exposed for connection to the tracheal prosthesis orpositioned in the nose or mouth. Furthermore, the portion of thecatheter disposed in the patient can be treated. For example, it can betreated with an antibacterial, a drug, a lubricious coating, a treatmentto prevent mucous formation, or otherwise.

FIG. 24 is a flow diagram illustrating an embodiment of a method of theinvention. In accordance with this embodiment of the invention, thepatient is provided with the system in accordance with the invention.The system is used to detect the spontaneous respiration of the patient.At or near the peak of inspiration flow, the system determines whetheradditional oxygen is needed by the patient. If yes, the system providesa jet boost of oxygen to the patient. Then at or near the peak ofexpiration flow, the system determines whether more carbon dioxide mustbe exhaled by the patient. If more must be exhaled, then the systemprovides a counter current of oxygen to the patient. The process isrepeated as needed. The advantage of this embodiment is to allow thetherapy to match the needs of the patient. Other ventilator systems tendto apply a predetermined therapy regardless of the changing condition ofthe patient, until a clinician changes a setting on the ventilator.Other ventilator systems are therapeutically suboptimal for a wide rangeof patient situations, often leading to over treatment, making thepatient too dependent on artificial ventilation, or leading to undertreatment, and thus worsening the patient's clinical condition.Therefore, in accordance with this invention the ventilator will adjustan output to the patient based on the patient's need. The ventilator canmake a determination by using patient information already obtained bythe sensors, such as breath rate, depth of respiration, length ofinspiration or exhalation, agitation, or gas concentration levels. Forexample, if a patient is exercising and an unusually low exhalation flowrate is detected by the sensors, indicating that airways are collapsingtoo much during exhalation, then, exhalation counter flow could beswitched on or increased to prop the airways open and enhance exhaledflow. Or, for example, if the patient's breathing becomes unusually fastas measured by the breath sensors, indicating the patient iscompensating for shortness of breath, the inspiratory augmentation pulsecould be switched on or increased to relieve the patient's dyspnea. Oras another example, gas composition sensors detecting CO₂ and O₂ levelsin the airway can determine if the therapy is adequate and increase orlower the therapy as needed.

As mentioned above, the principles of the invention can be used intreating and/or assisting in the treatment of a variety of breathingdisorders and/or breathing difficulties. In such treatments, theinvention can provide an oxygen-bearing gas into any of the airways ofthe patient. In one such embodiment, instead of directing theoxygen-bearing gas into the lungs, the oxygen-bearing gas can bedirected into the upper airways, including, for example, using acatheter and, more particularly, a tracheal or coated catheter.

In one embodiment, an oxygen-bearing gas can be directed into the upperairways to treat or assist in the treatment of sleep apnea. Sleep apneais a serious sleep disorder that occurs when a person's breathing isinterrupted repeatedly during their sleep. People with untreated sleepapnea stop breathing repeatedly during their sleep, sometimes hundredsof times during the night. One type of sleep apnea can be referred to asobstructive sleep apnea (OSA). OSA is caused by a blockage of theairway, usually when the soft tissue in the rear of the throat collapsesduring sleep. Currently, sleep apnea can be treated by continuouspositive airway pressure (CPAP) treatment in which a patient wears amask over the nose and/or mouth. An air blower forces air through theupper airway. The air pressure is adjusted so that it is just enough toprevent the upper airway tissue from collapsing during sleep. Thepressure is constant and continuous, and the flow rate is sometimesadjusted by bilevel positive airways pressure (BiPAP) machines,depending on need. CPAP can prevent airway closure while in use, butapnea episodes return when CPAP is stopped or it is used improperly. Theuse of the nasal mask and oral delivery of gas/oxygen/ambient air iscumbersome and inhibits the patient. In contrast, in accordance with theprinciples of the invention, the oxygen-bearing gas can be provided tothe patient by way of a catheter, including a tracheal catheter. Theoxygen-bearing gas can be provided to the patient based upon thebreathing monitored by sensors in accordance with the invention. Thisincludes sensors placed in the upper airway tissues that sense tissuemovement or collapse. These sensors could communicate to the pump viawireless or hard wire. The sensors can detect the breathing cycles andbased upon that information the oxygen flow and volume can becontrolled. The oxygen-bearing gas can be provided continuously,intermittently, or pulsed as needed. Alternatively, as discussed above,the oxygen-bearing gas can be provided in a jet flow. Further, theportable respiration device can be programmed such that a continuousflow of oxygen-bearing gas is delivered and a jet boost is activatedonly if necessary. As a result, the oxygen can be tailored to thepatient's needs.

The invention can be used to treat any kind of disease where alveolarventilation and oxygen uptake are impaired. This includes chronicobstructive airway pulmonary diseases including lung emphysema, as wellas restrictive diseases such as pulmonary fibrosis, sarcoidosis, pleuraladhesions, chest-wall diseases, neuromuscular diseases, and phrenicnerve paralysis. Basically, whenever a patient has a problem breathingdeeply enough, the invention can be helpful.

In contrast to the present invention, typical invasive ventilation isprovided all the time, but a patient cannot exercise at all (walk carrysomething, etc.). The patient has a tube in the throat and is fixed to abed (usually in intensive care). Non-invasive ventilation with a mask issometimes provided in order to help the patient's weak breathing musclesrecover. For example, if the patient is ventilated overnight, thediaphragm and auxiliary muscles can rest, and the patient can performbetter at daytime. However, whenever the patient would need help most(during exercise), the patient has to breathe on their own. With theminimally invasive or percutaneous ventilation and the synchronized jetfrom the system in accordance with the invention, support is given whenneeded (e.g., during exercise).

Although the foregoing description is directed to the preferredembodiments of the invention, it is noted that other variations andmodifications will be apparent to those skilled in the art, and may bemade departing from the spirit or scope of the invention. Moreover,features described in connection with one embodiment of the inventionmay be used in conjunction with other embodiments, even if notexplicitly stated above. The present invention may be embodied in otherspecific forms without departing from its spirit or essentialcharacteristics. The described embodiments are to be considered in allrespects only as illustrative and not restrictive. The scope of theinvention is, therefore, indicated by the appended claims, rather thanby the foregoing description. All changes, which come within the meaningand range of equivalency of the claims, are to be embraced within theirscope.

1. An apparatus for supplementing respiration of a spontaneouslybreathing patient comprising: an oxygen-bearing gas source, patientrespiration sensors for detecting spontaneous respiration phases of thepatient a catheter adapted to be inserted into the respiratory system ofthe patient and fluidly connected to the oxygen-bearing gas source, anda control unit in communication with the patient respiration sensors,the control unit adapted and configured to determine a need for anadditional amount of gas based on the patient's need as determined by ameasurement of the patient's respiration and to control theoxygen-bearing gas source to deliver a volume of gas to the patientthrough the catheter in synchrony with a portion of the patient'sspontaneous breathing pattern when the patient needs respiratorysupport.
 2. The apparatus of claim 1, wherein at least one of thepatient respiration sensors are selected from the group consisting of:thermistors, pressure sensors, silicone wire strain gauges, respibands,respitrace, transthoracical electrical impedance measuring devices, flowsensors at the mouth or nose, and capnometers.
 3. The apparatus of claim1, wherein the patient respiration sensors are used for ventilationcontrol and connected to the control unit wirelessly.
 4. The apparatusof claim 1, wherein the catheter is connected to a low profile trachealprosthesis configured to be placed within a trachea without occludingthe airway while maintaining tracheal patency and preventing therespiration sensor from contacting the tracheal wall.
 5. The apparatusof claim 4, wherein the tracheal prosthesis further comprises prongs orpetals that are configured to be positioned on at least one of ananterior wall of a trachea and or a neck surface of the patient and tosecure the prosthesis in place.
 6. The apparatus of claim 4, wherein thetracheal prosthesis further comprises an antibacterial, a drug, alubricious coating, hydrogel anesthetics, a treatment to preventgranulation tissue, or a treatment to prevent mucous formation coating.7. The apparatus of claim 1, wherein the catheter further comprises ajet nozzle.
 8. The apparatus of claim 7, wherein an exit port of thecatheter is substantially centered in the trachea though the use ofcoils or bends in the catheter configured to touch the walls of thetrachea.
 9. The apparatus of claim 7, wherein the catheter furthercomprises clips or balloons adapted to position the catheter in atracheal lumen, wherein the clips or balloons are non-obstructive and donot obstruct an airway when inserted into a tracheal lumen.
 10. Theapparatus of claim 9, wherein the catheter has a single circumferentialballoon or a plurality of balloons.
 11. The apparatus of claim 9,wherein the clips are made of a resilient material.
 12. The apparatus ofclaim 1, wherein the catheter comprises an inner lumen and an outerlumen each for gas flow.
 13. The apparatus of claim 12, wherein the wallof the outer lumen comprises a plurality of gas exit ports that areconfigured to create airflow profiles in the trachea.
 14. The apparatusof claim 13, wherein the plurality of ports are substantially circular,hexagonal, oval, or slits.
 15. The apparatus of claim 13, wherein thecatheter further comprises a flow regulator adapted to regulate the flowof oxygen-bearing gas through the ports.
 16. The apparatus of claim 15,wherein the flow regulator is selected from the group consisting of: agliding sheath, shutters, louvers, and slats.
 17. The apparatus of claim1, wherein the apparatus is a modular component.
 18. The apparatus ofclaim 1, wherein at least one sensor is a nanotechnology device.
 19. Theapparatus of claim 1, wherein oxygen-bearing gas from the oxygen-bearinggas source further comprises fragrances, aerosolized drugs, or water.20. The apparatus of claim 1, wherein oxygen-bearing gas from theoxygen-bearing gas source is heated.
 21. The apparatus of claim 1,wherein the control unit is configured to determine when a patient'srespiration is in need of mechanical support based on the informationreceived by the control unit from the respiration sensors.
 22. Theapparatus of claim 1, wherein the sensors comprise at least two sensorsand the two sensors are disposed at different locations.
 23. Theapparatus of claim 22, wherein the sensors comprise a first and a secondsensor, and the first sensor is configured so that a signal response ofa first sensor is dampened relative to a signal response of the secondsensor, and further comprising a logic for comparing the signalresponses of the first and second sensors for correcting signal drift,transient signals and artifacts.
 24. The apparatus of claim 1, furthercomprising a gas pump operatively connected to the oxygen-bearing gassource, wherein the gas pump, oxygen-bearing gas source, and controlunit are housed together.
 25. A method for supplementing the respirationof a spontaneously breathing patient comprising the steps of: insertinga catheter into the respiratory system of the patient so that thecatheter does not hinder the patient's ability to speak or breathespontaneously through the upper airway, determining the phases ofspontaneous respiration of the patient with respiration sensorsincluding beginning and end of breath phases, administering asupplemental volume of oxygen-bearing gas based on the patient's need asdetermined by a measurement of the patient's respiration to the lungs ata gas flow speed of greater than 100 m/sec., wherein the delivery issynchronized with a portion of the patient's spontaneous respirationphases.
 26. The method of claim 25, wherein the supplementaloxygen-bearing gas is administered simultaneously with a continuous flowof oxygen-bearing gas.
 27. The method of claim 25, wherein therespiration sensors are selected from the group consisting of:thermistors, pressure sensors, silicone wire strain gauges, respibands,respitrace, transthoracical electrical impedance measuring devices, flowsensors at the mouth or nose, and capnometers.
 28. The method of claim25, further comprising connecting the catheter to a tracheal prosthesisthat is configured to not occlude an airway.
 29. The method of claim 28,further comprising securing the tracheal prosthesis in a trachea withprongs or petals, wherein the prongs or petals are positioned on ananterior wall of a trachea and or a neck surface of the patient and theprongs or petals secure the prosthesis in place.
 30. The method of claim28, further comprising supplying an antibacterial, a drug, a lubriciouscoating, hydrogel anesthetics, a treatment to prevent granulationtissue, or a treatment to prevent mucous formation to the patient byproviding a tracheal prosthesis coated thereof.
 31. The method of claim25, wherein the step of inserting the catheter comprises inserting acatheter having an exit port, wherein the exit port of the catheter issubstantially centered in the patient's trachea.
 32. The method of claim31, wherein the step of inserting the catheter having an exit portcomprises substantially centering the exit port of the catheter in thetrachea through the use of coils or bends in the catheter touching thewails of the trachea.
 33. The method of claim 31, wherein the step ofinserting the catheter having an exit port comprises substantiallycentering the exit port of the catheter in the trachea though the use ofclips or balloons attached to the catheter and the clips or balloons areconfigured to not seal or obstruct an airway.
 34. The method of claim33, wherein the step of substantially centering the catheter comprisessubstantially centering a catheter having a single circumferentialballoon or a plurality of balloons.
 35. The method of claim 33, whereinthe step of substantially centering the catheter comprises substantiallycentering a catheter having clips made of a resilient material.
 36. Themethod of claim 25, wherein the step of inserting the catheter comprisesinserting the catheter into the patient's respiratory system by way ofthe mouth or nose.
 37. The method of claim 25, wherein the step ofinserting the catheter comprises inserting a catheter having an outerlumen and an inner lumen, and wherein a wall of the outer lumencomprises a plurality of gas exit ports that are configured to createairflow profiles in a trachea.
 38. The method of claim 37, wherein thestep of administering comprises administering the oxygen-bearing gasthrough the inner lumen during inhalation and administering theoxygen-bearing gas through the outer lumen during exhalation.
 39. Themethod of claim 25, further comprising applying vibratory flow toimprove mucus clearance.
 40. The method of claim 25, further comprisingsensing high pressure in the trachea and shutting off the administrationof oxygen-bearing gas.
 41. The method of claim 25, wherein the step ofadministering a supplemental amount of oxygen-bearing gas comprisesadministering a supplemental amount of oxygen-bearing gas selected fromthe group consisting of: substantially pure oxygen, mixtures of oxygenand nitrogen, mixtures of oxygen and inert gases, ambient air, andvarious combinations thereof.
 42. The method of claim 41, wherein thestep of administering a supplemental amount of oxygen-bearing gasfurther comprises administering a supplemental amount of oxygen-bearinggas comprising fragrances, aerosolized drugs, or water.
 43. The methodof claim 41, further comprising heating the oxygen-bearing gas.
 44. Themethod of claim 25, further comprising determining when the patient'srespiration is in need of mechanical support, based on informationreceived by the control unit from the breath sensors. 45.-59. (canceled)60. A method for supplementing the respiration of a spontaneouslybreathing patient comprising the steps of: inserting an oxygen-bearinggas delivery device into the respiratory system of the patient,detecting spontaneous respiration of the patient with respirationsensors, identifying an inhalation phase and an exhalation phase usinginformation from the respiration sensors, synchronizing delivery of avolume of oxygen-bearing gas based on the patient's need as determinedby a measurement of the patient's respiration to the patient during aninhalation phase to augment inspiration or during an exhalation phase toaugment exhalation, and wherein the delivered volume of theoxygen-bearing gas is increased, decreased, switched-on or switched-offbased on feedback from the respiration sensors.
 61. A device forsupplementing the respiration of a spontaneously breathing patientcomprising sensors for monitoring the spontaneous respiration of thepatient a catheter configured to be inserted into the respiratory systemof the patient, a control unit communicating with the sensors configuredto identify an inhalation and an exhalation phase of the patient'sspontaneous respiration and the need for supplemental gas volume basedon the patient's need as determined by a measurement of the patient'srespiration wherein the control unit is further configured to administera supplemental amount of oxygen-bearing gas through the cathetersynchronously with either an inhalation phase or an exhalation phase,and wherein the supplemental volume of the oxygen-bearing gas isincreased, decreased, switched-on or switched-off based on feedback fromthe sensors.
 62. A system for supplementing the respiration of aspontaneously breathing patient, comprising: a transtracheal catheteradapted for placement in an airway of a patient and comprising at leastone respiration sensor, wherein the transtracheal catheter is configuredto not obstruct an airway of the patient; and a wearable mobilerespiratory device comprising: a control unit in communication with therespiration sensor, the control unit configured to determine the needfor additional volume based on the patient's need as determined by ameasurement of the patient's respiration and to control the delivery ofa volume of supplemental gas to the patient in synchrony with a portionof the patient's spontaneous breathing pattern when the need for breathaugmentation is determined.
 63. The system of claim 62, wherein thecatheter is connected to a tracheal prosthesis configured to be placedwithin a trachea without occluding the airway while maintaining trachealpatency and preventing the respiration sensor from contacting thetracheal wall.
 64. The device of claim 61, wherein the supplementalvolume of oxygen-bearing gas is administered at a gas flow speed ofgreater than 100 m/s.
 65. The device of claim 61, wherein thesupplemental volume of oxygen-bearing gas is administered at a gas flowspeed of between about 100 m/s to about 300 m/s.
 66. The method of claim60, further comprising: determining at or near a peak of the inhalationphase whether the volume of oxygen-bearing gas is needed by the patient.67. The method of claim 60, further comprising: determining at or near apeak of the exhalation phase whether more carbon dioxide needs to beexhaled by the patient.
 68. The method of claim 60, further comprising:detecting gas composition in the airway to determine whether to adjustthe delivery of the supplemental volume of oxygen-bearing gas.
 69. Theapparatus of claim 1, wherein the control unit is configured todetermine a need for additional volume of gas based on input from thepatient respiration sensors and is further configured to control theoxygen-bearing gas source to increase, decrease, switch-on or switch-offthe delivery of the volume of gas based on the need determined.
 70. Themethod of claim 44, wherein the step of administering a supplementalamount of oxygen-bearing gas comprises administering a supplementalamount of oxygen-bearing as to the lungs when the patient is in need ofmechanical support.
 71. The method of claim 44, further comprisingproviding a continuous flow of oxygen-bearing gas in addition toadministering a supplemental amount of oxygen-bearing gas.